OPTION-EMEA Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Croatia, France, Italy, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]
Overview
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case. The study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.
Interventions
- Device Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case
left atrial appendage closure - Procedure Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
FARAPULSE PFA and WATCHMAN FLX Pro or WATCHMAN FLX in one interventional case.
Primary outcome measures
- Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events [Time frame: 30 days following the index procedure.]
- Primary Efficacy Endpoint (PEE): Acute Treatment Success [Time frame: Through 30 days]
Eligibility criteria
Inclusion criteria
- Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care.
- Subjects who are willing and able to provide informed consent.
- Subjects who are willing and able to participate in all testing associated with this clinical study at an approved investigational center.
- Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Exclusion criteria
- Subjects who underwent prior AF ablation procedure.
- Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
- Already surgically closed or otherwise excluded LAA.
- The LAA anatomy does not accommodate a Closure Device.
- Known or suspected atrial myxoma.
- Presence of intracardiac thrombus\*.
- Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) / patent foramen ovale (PFO) device.
- Subjects with a presence of a mechanical valve prosthesis in any position.
- Subjects with a myocardial infarction within 90 days prior to enrollment.
- Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment.
- Any planned electrical cardioversion within 30 days following LAAC device implant.
- Subjects with a known inability to obtain vascular access.
- Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present.
- Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina).
- Subjects with any contraindications to short term use of anticoagulation therapy for conditions different from atrial fibrillation.
- Subjects who are pregnant or planning to be pregnant.
- Subjects with a life expectancy of ≤ 1 year per investigator's opinion.
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Belgium · 1 center
- AZORG - Hospital — Aalst
Croatia · 1 center
- Klinicki bolnicki centar Zagreb — Zagreb
France · 1 center
- Clinique Pasteur - Toulouse — Toulouse
Italy · 1 center
- IRCCS Policlinico San Donato — San Donato Milanese
Spain · 1 center
- University Hospital of Salamanca — Salamanca
Identifiers
NCT: NCT07349121 · S2605